Complex Treatment of a Chronic Anal Fissure

NCT03855046 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 56IG701SSCC978
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 7

Brief Summary

This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.

Conditions

Fissure in Ano

Keywords

Internal sphincterotomy; Anal fissure; Chronic anal fissure; botulinum toxin A; proctologic diseases; surgical treatment; Chronic anal pain; Fecal incontinence; Spasm of the internal sphincter; Anal sphincter insufficiency; randomized

Outcome Measures

Primary Outcomes (1)

• Anal sphincter insufficiency

  Frequency of anal sphincter insufficiency according to the Wexner scale incontinence after the surgical intervention. Self reported daily meausure outcome, wich evaluate from 0 - to 20 points (where 0 points = full feacal continence; 20 points = full feacal incontinence).

  Up to 60 days

Secondary Outcomes (5)

• 2-item pain intensity (P2)

  On day 7, 30 and 60

• Non-Healing Wound

  On day 60

• Profilometry /sphincterometry findings

  On day 30 and 60

• Temporary disability

  Up to 60 days

• Relap

  Up to 60 days

Study Arms (2)

Xeomin

EXPERIMENTAL

Complex treatment of chronic anal fissure with drug-induced relaxation of the internal sphincter with Botulinum Toxin Type A. (IncobotulinumtoxinA 50 U Intramuscular Powder for Solution).

Drug: IncobotulinumtoxinA 50 U Intramuscular Powder for Solution

Xeomin control

ACTIVE COMPARATOR

Complex treatment of chronic anal fissure with lateral subcutaneous sphincterotomy.

Procedure: Lateral subcutaneous sphincterotomy.

Interventions

IncobotulinumtoxinA 50 U Intramuscular Powder for Solution DRUG

Sparing surgical removal of fissure without internal sphincter incision is held under spinal anesthesia in surgical room at lithotomy position using electrocoagulation. After that Botulinum Toxin Type A is injected into the internal anal sphincter at 1, 5, 7 and 11 o'clock (localization of injection points), 10 U at each point (40 U in total). Botulinum toxin type A (a 50 U vial) is diluted with 1.0 ml of 0.9% saline solution.

Also known as: Xeomin

Xeomin

Lateral subcutaneous sphincterotomy. PROCEDURE

The patient is positioned on the table like for perineal lithotomy. After spinal anesthesia, the anal canal and then the surgical field are treated with 70% ethanol. Under the rectal speculum control, sparing surgical removal of fissure without internal sphincter incision is held using electrocoagulation.Then, in a 3 or 9 o'clock position, a narrow (eye) scalpel is inserted into the intersphincteric groove separating the external and internal sphincters, the scalpel blade is turned to the rectal lumen, and the internal sphincter is dissected up to the wall of the anal canal mucosa under the control of the finger inserted into the anal canal. After controlling hemostasis, the operation is ended with the introduction of the vent tube and hemostatic sponge.

Xeomin control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic anal fissure

You may not qualify if:

• Inflammatory diseases of the colon
• Pectenosis
• Previous surgical interventions on the anal canal
• IV grade internal and external hemorrhoids
• Rectal fistula
• Severe somatic diseases at the decompensation stage
• Pregnancy and lactation
• Individual intolerance and hypersensitivity to botulinum toxin
• Myasthenia gravis and myasthenia-like syndromes
• Anal sphincter insufficiency

Sponsors & Collaborators

• State Scientific Centre of Coloproctology, Russian Federation: lead
• St. Petersburg State Pavlov Medical University: collaborator
• Astrakhan State Medical University: collaborator
• Siberian State Medical University: collaborator
• City Clinical Hospital №24, Department of Health City of Moscow: collaborator
• GBUZ MO "Lvovskaia Raionaia Bolnica": collaborator
• Medical Center ON-CLINIC: collaborator

Study Sites (7)

GBUZ MO "Lvovskaia Raionaia Bolnica"

Podolsk, Moscow Oblast, 142155, Russia

RECRUITING

Astrakhan State Medical University

Astrakhan, Russia

RECRUITING

Medical Center ON-CLINIC

Moscow, 119034, Russia

RECRUITING

SSCCRussia

Moscow, 123423, Russia

RECRUITING

City Clinical Hospital №24, Department of Health City of Moscow

Moscow, Russia

RECRUITING

St. Petersburg State Pavlov Medical University

Saint Petersburg, Russia

RECRUITING

Siberian State Medical University

Tomsk, Russia

RECRUITING

Related Publications (24)

• Stewart DB Sr, Gaertner W, Glasgow S, Migaly J, Feingold D, Steele SR. Clinical Practice Guideline for the Management of Anal Fissures. Dis Colon Rectum. 2017 Jan;60(1):7-14. doi: 10.1097/DCR.0000000000000735. No abstract available.

  PMID: 27926552 BACKGROUND

• Sohn N, Eisenberg MM, Weinstein MA, Lugo RN, Ader J. Precise anorectal sphincter dilatation--its role in the therapy of anal fissures. Dis Colon Rectum. 1992 Apr;35(4):322-7. doi: 10.1007/BF02048108.

  PMID: 1582352 BACKGROUND

• Renzi A, Izzo D, Di Sarno G, Talento P, Torelli F, Izzo G, Di Martino N. Clinical, manometric, and ultrasonographic results of pneumatic balloon dilatation vs. lateral internal sphincterotomy for chronic anal fissure: a prospective, randomized, controlled trial. Dis Colon Rectum. 2008 Jan;51(1):121-7. doi: 10.1007/s10350-007-9162-7. Epub 2007 Dec 15.

  PMID: 18080713 BACKGROUND

• Gui D, Cassetta E, Anastasio G, Bentivoglio AR, Maria G, Albanese A. Botulinum toxin for chronic anal fissure. Lancet. 1994 Oct 22;344(8930):1127-8. doi: 10.1016/s0140-6736(94)90633-5.

  PMID: 7934496 BACKGROUND

• Khan M.I., Khan H., Khan A.U., et. al. Comparing the efficacy of botulinum toxin injection and lateral internal sphincterotomy for chronic anal fissure. KJMS, 2016. 9(1): p. 6

  BACKGROUND

• Bobkiewicz A, Francuzik W, Krokowicz L, Studniarek A, Ledwosinski W, Paszkowski J, Drews M, Banasiewicz T. Botulinum Toxin Injection for Treatment of Chronic Anal Fissure: Is There Any Dose-Dependent Efficiency? A Meta-Analysis. World J Surg. 2016 Dec;40(12):3064-3072. doi: 10.1007/s00268-016-3693-9.

  PMID: 27539490 BACKGROUND

• Nasr M, Ezzat H, Elsebae M. Botulinum toxin injection versus lateral internal sphincterotomy in the treatment of chronic anal fissure: a randomized controlled trial. World J Surg. 2010 Nov;34(11):2730-4. doi: 10.1007/s00268-010-0736-5.

  PMID: 20703472 BACKGROUND

• Valizadeh N, Jalaly NY, Hassanzadeh M, Kamani F, Dadvar Z, Azizi S, Salehimarzijarani B. Botulinum toxin injection versus lateral internal sphincterotomy for the treatment of chronic anal fissure: randomized prospective controlled trial. Langenbecks Arch Surg. 2012 Oct;397(7):1093-8. doi: 10.1007/s00423-012-0948-2. Epub 2012 Mar 20.

  PMID: 22430300 BACKGROUND

• Magdy A, El Nakeeb A, Fouda el Y, Youssef M, Farid M. Comparative study of conventional lateral internal sphincterotomy, V-Y anoplasty, and tailored lateral internal sphincterotomy with V-Y anoplasty in the treatment of chronic anal fissure. J Gastrointest Surg. 2012 Oct;16(10):1955-62. doi: 10.1007/s11605-012-1984-5. Epub 2012 Aug 7.

  PMID: 22869534 BACKGROUND

• Katsinelos P, Papaziogas B, Koutelidakis I, Paroutoglou G, Dimiropoulos S, Souparis A, Atmatzidis K. Topical 0.5% nifedipine vs. lateral internal sphincterotomy for the treatment of chronic anal fissure: long-term follow-up. Int J Colorectal Dis. 2006 Mar;21(2):179-83. doi: 10.1007/s00384-005-0766-x. Epub 2005 Aug 10.

  PMID: 16091912 BACKGROUND

• Chen HL, Woo XB, Wang HS, Lin YJ, Luo HX, Chen YH, Chen CQ, Peng JS. Botulinum toxin injection versus lateral internal sphincterotomy for chronic anal fissure: a meta-analysis of randomized control trials. Tech Coloproctol. 2014 Aug;18(8):693-8. doi: 10.1007/s10151-014-1121-4. Epub 2014 Feb 6.

  PMID: 24500725 BACKGROUND

• Bagrasaryan LS, Surgical treatment of anal fissure with anal sphincter pneumodivulsion. 2010: p. 115

  BACKGROUND

• Delechenaut P, Leroi AM, Weber J, Touchais JY, Czernichow P, Denis P. Relationship between clinical symptoms of anal incontinence and the results of anorectal manometry. Dis Colon Rectum. 1992 Sep;35(9):847-9. doi: 10.1007/BF02047871.

  PMID: 1511644 BACKGROUND

• Hyman N. Incontinence after lateral internal sphincterotomy: a prospective study and quality of life assessment. Dis Colon Rectum. 2004 Jan;47(1):35-8. doi: 10.1007/s10350-003-0002-0. Epub 2004 Jan 14.

  PMID: 14719148 BACKGROUND

• Sultan AH, Kamm MA, Hudson CN, Thomas JM, Bartram CI. Anal-sphincter disruption during vaginal delivery. N Engl J Med. 1993 Dec 23;329(26):1905-11. doi: 10.1056/NEJM199312233292601.

  PMID: 8247054 BACKGROUND

• Tjandra JJ, Han WR, Ooi BS, Nagesh A, Thorne M. Faecal incontinence after lateral internal sphincterotomy is often associated with coexisting occult sphincter defects: a study using endoanal ultrasonography. ANZ J Surg. 2001 Oct;71(10):598-602. doi: 10.1046/j.1445-2197.2001.02211.x.

  PMID: 11552935 BACKGROUND

• Zetterstrom J, Mellgren A, Jensen LL, Wong WD, Kim DG, Lowry AC, Madoff RD, Congilosi SM. Effect of delivery on anal sphincter morphology and function. Dis Colon Rectum. 1999 Oct;42(10):1253-60. doi: 10.1007/BF02234209.

  PMID: 10528760 BACKGROUND

• Khubchandani IT, Reed JF. Sequelae of internal sphincterotomy for chronic fissure in ano. Br J Surg. 1989 May;76(5):431-4. doi: 10.1002/bjs.1800760504.

  PMID: 2736353 BACKGROUND

• Zbar A., M. Aslam, and V. Allgar, Faecal incontinence after internal sphincterotomy for anal fissure. Techniques in Coloproctology, 2000. 4(1): p. 25-28.

  BACKGROUND

• Zharkov, EE, Comprehensive treatment of chronic anal fissure. 2009: p. 126.

  BACKGROUND

• Iswariah H, Stephens J, Rieger N, Rodda D, Hewett P. Randomized prospective controlled trial of lateral internal sphincterotomy versus injection of botulinum toxin for the treatment of idiopathic fissure in ano. ANZ J Surg. 2005 Jul;75(7):553-5. doi: 10.1111/j.1445-2197.2005.03427.x.

  PMID: 15972045 BACKGROUND

• Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.

  PMID: 22336789 BACKGROUND

• Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.

  PMID: 8416784 BACKGROUND

• Jorge JM, Wexner SD. Anorectal manometry: techniques and clinical applications. South Med J. 1993 Aug;86(8):924-31. doi: 10.1097/00007611-199308000-00016.

  PMID: 8351556 BACKGROUND

MeSH Terms

Conditions

Fissure in Ano; Fecal Incontinence

Interventions

incobotulinumtoxinA; Solutions

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Sergey A. Frolov, Ph.D.

  State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evgeny E. Zharkov, MD

CONTACT

89039689739; drzharkov@mail.ru

Roman Yu. Khryukin, MD

CONTACT

+79161598059; texnik.lip@yandex.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A multicenter, prospective, randomized, controlled clinical study. Surgical removal of anal fissure followed by internal sphincter relaxation with Botulinum toxin type A is performed in the study group. Lateral subcutaneous sphincterotomy to relax sphincter is a method of choice in the control group. Patients are randomized with envelope method

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 26, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: November 1, 2022
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (7)